NCT01109576

Brief Summary

This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

April 19, 2010

Results QC Date

June 4, 2015

Last Update Submit

August 28, 2015

Conditions

Keywords

deafness-blindnesspilot studyself management educationdual sensory lossrehabilitationpeer support groupsage related

Outcome Measures

Primary Outcomes (1)

  • Change in Profile of Mood States Total Score.

    The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.

    Change in Profile of Mood States Score from Baseline to 8 Weeks

Study Arms (1)

DSL workshop participants

EXPERIMENTAL

Three to five Veterans with DSL.

Behavioral: DSL Workshop

Interventions

DSL WorkshopBEHAVIORAL

A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.

Also known as: Dual Sensory Loss Self Management Groups
DSL workshop participants

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran;
  • Vision loss \> 20/70 better eye;
  • Hearing loss \> 40 decibels better ear;
  • Cognition Within Normal Limits (WNL);
  • No behavioral flag or psychiatric diagnosis;
  • Documented psychosocial restrictions secondary to vision and hearing loss

You may not qualify if:

  • Vision and/or hearing can be corrected by surgical or pharmacological treatment;
  • Requires use of sign language interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

DeafnessBlindnessDeaf-Blind Disorders

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVision DisordersEye DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The sample size was too small to draw any definitive conclusion from the data.

Results Point of Contact

Title
Mitchel Turbin, PhD
Organization
VHAPORHCS

Study Officials

  • Mitchel Turbin, PhD

    Veterans Health Administration (VHA)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 23, 2010

Study Start

November 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2013

Last Updated

September 29, 2015

Results First Posted

September 29, 2015

Record last verified: 2015-08

Locations